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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT04820894
Other study ID # 19322
Secondary ID NCI-2021-0181819
Status Withdrawn
Phase
First received
Last updated
Start date October 30, 2021
Est. completion date March 30, 2023

Study information

Verified date February 2022
Source City of Hope Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study collects information about perception of cure among patients with cancer that has spread to other places in the body (metastatic). This study aims to determine patients' perception (knowledge) before starting immunotherapy and if differences exist in understanding of treatment to stimulate or restore the ability of the body's immune (defense) system to fight infection and disease (immunotherapy) based on social and economic factors or on race/ethnicity.


Description:

PRIMARY OBJECTIVE: I. To assess the proportion of patients with metastatic cancer who anticipate cure before starting immunotherapy. SECONDARY OBJECTIVES: I. To determine if expectations of cure are associated with quality of life and distress. II. To determine if patients' perceptions differ by gender, age, and ethnicity. OUTLINE: Patients complete surveys over 30 minutes about sociodemographic information and perception of immunotherapy, over 10 minutes about expectations of cure, over 10 minutes about anxiety, over 10 minutes about depression, and over 30 minutes about physical well-being. Patients' medical records are reviewed.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date March 30, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Eligibility Criteria: 1. Patients must be aged 18 and over 2. Patients sufficiently fluent in English 3. Patients must have a cytologically or pathologically verified diagnosis of cancer 4. Patients must have measurable metastatic disease 5. Patients must be initiating immunotherapy 6. Patients must be undergoing evaluation and treatment at City of Hope Cancer Center

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Electronic Medical Record
Medical records are reviewed
Survey Administration
Complete surveys

Locations

Country Name City State
United States City of Hope Medical Center Duarte California

Sponsors (2)

Lead Sponsor Collaborator
City of Hope Medical Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of patients Will assess the percentage of patients who anticipate cure before starting immunotherapy, scoring a '1' on the Perception of cure tool, and anticipate >75% chance for a cure. Up to 2 years
Primary Patient Reported Outcomes Measurement Information System (PROMIS) Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Patient Reported Outcomes Measurement Information System (PROMIS) tool score with perception of cure score. Up to 2 years
Primary Functional Assessment of Cancer Therapy-General (FACT-G) Descriptive analyses (e.g. frequency statistics) will be used to characterize the sample and to look at the association between Functional Assessment of Cancer Therapy-General (FACT-G) overall score with perception of cure score. Up to 2 years
Primary Perceptions of cure Chi-square analyses will be used to examine perceptions of cure by sociodemographic characteristics:
gender (male and female), age (< 60 and > 60), and ethnicity (white non-Hispanic, Hispanic, and other).
Up to 2 years
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